CN118216969A

CN118216969A - Device for sealing puncture hole

Info

Publication number: CN118216969A
Application number: CN202410522834.2A
Authority: CN
Inventors: 李峥; 刘享承
Original assignee: Tongqiao Medical Technology Co ltd
Current assignee: Tongqiao Medical Technology Co ltd
Priority date: 2024-04-28
Filing date: 2024-04-28
Publication date: 2024-06-21

Abstract

The invention relates to the technical field of medical equipment, and discloses equipment for sealing a puncture hole, which comprises: a conveying rod; the balloon catheter comprises a catheter and a balloon communicated with the catheter, the catheter penetrates through the conveying rod, and the balloon is arranged at the distal end of the catheter and at least partially positioned at the outer side of the end part of the conveying rod; the pushing rod is arranged in a gap between the conveying rod and the guide pipe; a blocking agent section positioned inside the delivery rod at one end near the balloon; and the failure prevention section is arranged between the plugging agent section and the push rod. This a device for sealing puncture hole, through set up the section of preventing becoming invalid between shutoff agent section and push rod, thereby prevent that the section of becoming invalid can be with the shutoff agent section not be connected thereby make the section of preventing becoming invalid whether by push rod gap centre gripping can not influence the shutoff agent section, thereby prevent that the section of becoming invalid also can adopt to receive the extrusion and take place along the material of the axial deformation of equipment so that prevent that the section of becoming invalid can not be carried out in the push rod by the centre gripping because of the sacculus withdraws, avoided the shutoff agent section can not be carried out by equipment and lead to arranging the inefficacy.

Description

Device for sealing puncture hole

Technical Field

The invention relates to the technical field of medical equipment, in particular to equipment for sealing a puncture hole.

Background

In surgery, it is sometimes necessary to perform a puncture operation on a patient to withdraw a tissue sample, inject a drug, drain pus or effusion, perform an interventional operation, and the like. Common conditions requiring a puncture include diagnostic puncture, therapeutic puncture, anesthesia, blood examination, and the like. Puncture surgery creates a puncture hole, and after surgery, closure of the puncture hole typically requires appropriate treatment using various devices and biological solutions to prevent infection and promote healing, such as a blocking agent.

For example, patent number CN202211367668.0 discloses an occlusion hemostatic apparatus comprising: a housing; a pull tube, one end of which is movably connected with the shell, and the other end of which extends towards the distal end of the shell; a conduit passing through the pull tube and being axially movable relative to the pull tube; a sealant is positioned between the pull tube and the catheter and disposed proximate the distal end of the pull tube. After the first locking mechanism is unlocked, the pushing mechanism pushes the pushing tube to move to the far end, the sealant exposed in the tissue is pushed tightly and is attached to the blood vessel puncture hole and the tissue wall, and the sealant is extruded to be fully attached and compacted with the blood vessel outer wall, so that the blood vessel puncture hole is effectively plugged and stopped bleeding.

The plugging agent is loaded in a conveying rod of the plugging hemostatic device, and the working principle of the plugging agent is as follows: the conveying rod is inserted into the puncture hole, when the blood return hole enters blood, blood outflow can be observed, the condition that the blood flows out reaches a designated position is explained, physiological saline or other fillers are filled into the balloon through the catheter to enable the balloon to bulge, the conveying rod is pulled back again to enable the balloon to be clamped on a blood vessel to finish positioning of the plugging hemostatic device, at the moment, the conveying rod is pulled back continuously and the pushing rod is pushed to release plugging agent, and finally the fillers in the balloon are discharged through the catheter to enable the balloon to be contracted and then the balloon is pulled out.

However, prior art plugging devices, when sealing a puncture with a plugging agent, may require pushing out and squeezing the plugging agent through a push tube in the device, and then retracting the balloon after which the balloon is withdrawn into the push tube. In the process, the plugging agent can be influenced by the action force of forward compression of the push tube and withdrawal of the balloon, and meanwhile, the tail end of the plugging agent is easy to be clamped in a gap between the push tube and the balloon due to soft and easy expansion of the material of the plugging agent, so that the plugging agent is withdrawn from a human body along with the withdrawal of the device when the device is withdrawn, and finally, the plugging puncture is invalid.

Disclosure of Invention

(One) solving the technical problems

Aiming at the defects of the prior art, the invention provides equipment for sealing a puncture hole, which has the advantage of preventing the blocking agent from being carried out to cause failure when the equipment is withdrawn, and solves the problem that the blocking agent is carried out along with the human body when the equipment is withdrawn to cause the failure of the equipment.

(II) technical scheme

In order to achieve the above purpose, the present invention provides the following technical solutions:

an apparatus for sealing a puncture, comprising:

A conveying rod 1 for penetrating into the puncture hole;

the balloon catheter comprises a catheter 2 and a balloon 3 communicated with the catheter 2, wherein the catheter 2 is arranged in the conveying rod 1 in a penetrating way and is used for swelling or shrinking the balloon 3, the balloon 3 is arranged at the far end of the catheter 2 and is at least partially positioned outside the end part of the conveying rod 1, and the balloon 3 is used for positioning a vascular wall 92 when swelling;

a push rod 4 disposed in a gap between the transfer rod 1 and the guide pipe 2;

a blocking agent section 5 located inside the delivery rod 1 at an end near the balloon 3, said blocking agent section 5 being located in the gap between the catheter 2 and the delivery rod 1;

A failure prevention section 6 is arranged in a gap between the conveying rod 1 and the conduit 2 and is positioned between the plugging agent section 5 and the push rod 4 in the axial direction of the conveying rod 1, and the failure prevention section 6 is used for preventing the plugging agent section 5 from being carried out when the device is withdrawn.

Preferably, the plugging agent section 5 is in non-fixed connection with the failure prevention section 6, the end face of the plugging agent section 5 facing the failure prevention section 6 is non-adhesive with the end face of the failure prevention section 6 facing the plugging agent section 5, and the contact surface between the plugging agent section 5 and the failure prevention section 6 is non-adhesive when in contact;

and/or the failure prevention section 6 is not deformed in the axial direction of the device under compression.

Preferably, the end face of the plugging agent section 5 facing the failure prevention section 6 is level with the end face of the failure prevention section 6 facing the plugging agent section 5, and the end face of the plugging agent section 5 facing the failure prevention section 6 is parallel with the end face of the failure prevention section 6 facing the plugging agent section 5.

Preferably, the end face of the plugging agent section 5 facing the failure prevention section 6 and the end face of the failure prevention section 6 facing the plugging agent section 5 are perpendicular to the central axis of the conveying rod 1.

Preferably, the anti-failure section 6 is arranged at one end of the plugging agent section 5, which is close to the push rod 4, and the end face of the plugging agent section 5, which faces the anti-failure section 6, is mutually abutted with the end face of the anti-failure section 6, which faces the plugging agent section 5; the material hardness of the anti-failure section 6 is the same as that of the plugging agent section 5, or the material hardness of the anti-failure section 6 is greater than that of the plugging agent section 5 and less than that of the push rod 4.

Preferably, the anti-failure section 6 and the plugging agent section 5 are both sleeved outside the catheter 2, the cross section of the anti-failure section is annular or arc-shaped, and the inner diameter and the outer diameter of the anti-failure section 6 are respectively equal to the inner diameter and the outer diameter of the plugging agent section 5.

Preferably, the inner diameters of the plugging agent section 5 and the anti-failure section 6 are in the size range of 0.6-1.2mm, and the outer diameters of the plugging agent section 5 and the anti-failure section 6 are in the size range of 1.5-2.5mm.

Preferably, the total axial length of the plugging agent section 5 and the anti-failure section 6 is 15-20mm, and the axial length of the anti-failure section is 10% -30%.

Preferably, the material of the failure prevention section 6 is a biomedical material capable of being absorbed by human body, the biomedical material in the failure prevention section 6 comprises a high molecular polymer or a biological material, the high molecular polymer comprises at least one or a combination of polyethylene glycol polymer and derivatives thereof, polyglycolic acid, polylactic acid, polyvinyl alcohol, polyglycolic acid-polylactic acid copolymer, polylactide copolymer, chitosan, collagen, cellulose, sodium alginate, sodium hyaluronate and gelatin, and the biological material comprises at least one or a combination of animal cells, tissues and other extracts;

Or the material of the failure prevention section 6 is biomedical material which cannot be absorbed by human body.

Preferably, an additional preparation segment 501 is further disposed on the blocking agent segment 5, and the additional preparation segment 501 is a preparation having at least one special effect of adhering to blood vessels, promoting blood coagulation, locally relieving pain, promoting tissue repair and growth, and reducing inflammation.

(III) beneficial effects

Compared with the prior art, the invention provides a device for sealing a puncture hole, which comprises the following components

The beneficial effects are that:

1. This a device for sealing puncture hole, through set up between shutoff agent section and push rod and prevent the section of inefficacy, prevent that shutoff agent section from being held by the centre gripping when the sacculus withdraws to avoided the shutoff agent to bring out when the device withdraws from and lead to the shutoff agent to arrange inefficacy.

2. This a device for sealing puncture hole, through be close to the one end setting of push rod at the shutoff agent section with the non-fixed connection prevent the section that becomes invalid of shutoff agent section, no adhesion when the terminal surface contact of shutoff agent section and prevent the section that becomes invalid, thereby prevent that the section that becomes invalid and shutoff agent section do not form fixed connection and make prevent that the section that becomes invalid whether by push rod gap centre gripping can not influence the shutoff agent section, guaranteed that the shutoff agent section can not be taken out by the device and lead to the shutoff agent to arrange the inefficacy.

2. This a device for sealing puncture hole sets up the section of preventing becoming invalid through the one end that is close to the push rod at the shutoff agent section, and the section of preventing becoming invalid is through adopting and is received the extrusion when the sacculus withdraws and do not take place along the material of equipment axial deformation, when apparatus release shutoff agent section and prevent becoming invalid section get into the human body, the section of preventing becoming invalid receives the extrusion when the sacculus withdraws and does not take place along equipment axial deformation to prevent that the section of becoming invalid can not be carried out in the push rod by the centre gripping because of the sacculus withdraws, realize successful shutoff agent's arrangement.

Drawings

Fig. 1 is a schematic view showing the overall structure of the apparatus for sealing a puncture hole according to the present invention.

Fig. 2 is a schematic view of the structure of the area a of the apparatus for sealing a puncture of the present invention.

FIG. 3 is a schematic illustration of a sealant segment and a fail-safe segment of an apparatus for sealing a puncture of a subject invention.

Fig. 4 is a cross-sectional view of the a-zone portion of the apparatus for sealing a puncture of the present invention.

Fig. 5 is a schematic view of the structure of the area B in fig. 4 according to the present invention.

Fig. 6 is a schematic diagram of a structure of adding an additional formulation segment at the end of the plugging agent segment according to embodiment seven of the present invention.

Fig. 7 is a cross-sectional view of the present invention in human tissue as it is used.

Fig. 8 is a cross-sectional view of the present invention in human tissue after release of the blocking agent.

In the figure: 1. a conveying rod; 2. a conduit; 3. a balloon; 4. a push rod; 5. a plugging agent section; 6. an anti-failure section; 101. a blood return hole; 401. a cavity; 501. an additional formulation section; 91. human tissue; 92. a vessel wall; 93. blood.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In this context, the terms "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of an operator using the medical device, although "proximal" and "distal" are not limiting, "proximal" generally refers to an end of the medical device that is proximal to the operator during normal operation, and "distal" generally refers to an end that first enters the patient.

In this context, the left side of each view direction is the distal end and the right side is the proximal end. The respective configurations of the apparatus are described in detail below.

Embodiment one:

The embodiment provides a device for sealing a puncture hole, wherein a plugging agent section 5 and an anti-failure section 6 are in non-fixed connection, the anti-failure section can be carried out by the device or left in a human body when the device is withdrawn, and the anti-failure section adopts biomedical materials which can be absorbed by the human body and has the following technical characteristics.

Referring to fig. 1-7, an apparatus for sealing a puncture, comprising: a conveying rod 1 for penetrating into the puncture hole; the balloon catheter comprises a catheter 2 and a balloon 3 communicated with the catheter 2, the catheter 2 is arranged in the conveying rod 1 in a penetrating way, the catheter 2 is used for adding and extracting fillers to the balloon 3 to enable the balloon 3 to bulge or shrink, the balloon 3 is arranged at the far end of the catheter 2 and at least partially positioned at the outer side of the end part of the conveying rod 1, and the balloon 3 is used for positioning a blood vessel 92 when the balloon 3 bulges; a push rod 4 disposed in a gap between the transfer rod 1 and the guide pipe 2; a blocking agent section 5 located inside the delivery rod 1 at an end near the balloon 3, the blocking agent section 5 being located in a gap between the delivery rod 1 and the catheter 2 in a radial direction of the delivery rod 1 and in a gap between the balloon 3 and the push rod 4 in an axial direction; the anti-failure section 6 is arranged in a gap between the conveying rod 1 and the guide pipe in the radial direction of the conveying rod 1, is positioned between the plugging agent section 5 and the push rod 4 in the axial direction of the conveying rod 1, and the anti-failure section 6 is used for preventing the plugging agent section 5 from being carried out when the device is withdrawn.

The plugging agent section 5 is further arranged in non-fixed connection with the failure prevention section 6, the end face of the plugging agent section 5 facing the failure prevention section 6 is non-adhesive with the end face of the failure prevention section 6 facing the plugging agent section 5, and the contact surface between the plugging agent section 5 and the failure prevention section 6 is non-adhesive when in contact. So, when sacculus 3 withdraws and leads to prevent that inefficacy section 6 is when being held in push rod 4, prevent that inefficacy section 6 and plugging agent section 5 do not take place the adhesion, guaranteed that plugging agent section 5 and prevent inefficacy section 6 can effectively separate to take out plugging agent section 5 when having avoided equipment to withdraw from, avoided plugging agent to arrange inefficacy.

The sealing agent section 5 is smooth and burr-free towards the end face of the anti-failure section 6 and the end face of the anti-failure section 6 towards the sealing agent section 5, and therefore embedded connection is not easy to occur when the sealing agent section is subjected to extrusion force, and the sealing agent section 5 and the anti-failure section 6 can be effectively separated.

The sealing agent section 5 is parallel to the end face of the anti-failure section 6 facing the sealing agent section 5, so that the sealing agent section is prevented from being clamped due to partial deformation of the sealing agent section caused by uneven stress between the sealing agent section 5 and the anti-failure section 6.

Further, in this embodiment, the end face of the plugging agent section 5 facing the failure prevention section 6 and the end face of the failure prevention section 6 facing the plugging agent section 5 are perpendicular to the central axis of the conveying rod 1. Therefore, the acting force between the plugging agent section 5 and the failure prevention section 6 is parallel to the central axis of the conveying rod 1, the plugging agent can be pushed out and tamped by using relatively small force to squeeze, the partial deformation of the plugging agent section 5 and the influence on the inner wall of the conveying rod 1 caused by the squeezing process are reduced, and the situation that the plugging agent section is clamped due to the nested deformation caused by the partial deformation of the plugging agent section 5 due to uneven stress when the balloon 3 is retracted is avoided.

Further provided, the anti-failure section 6 is arranged at one end of the plugging agent section 5, which is close to the push rod 4, and the end face of the plugging agent section 5, which faces the anti-failure section 6, and the end face of the anti-failure section 6, which faces the plugging agent section 5, are mutually abutted. The plugging agent section 5 is mutually abutted with the failure prevention section 6, so that displacement difference in the radial direction between the plugging agent section 5 and the failure prevention section 6 during extrusion of the push rod 4 can be prevented to the greatest extent, and the plugging agent section is clamped due to the fact that the plugging agent section 5 is deformed to form nested deformation due to the fact that a part of stressed part of the plugging agent section 5 is not stressed.

The material hardness of the anti-failure section 6 is the same as that of the plugging agent section 5, or the material hardness of the anti-failure section 6 is greater than that of the plugging agent section 5 and less than that of the push rod 4. Further, the hardness difference between the failure prevention section 6 and the plugging agent section 5 is in the range of 0-20 degrees. Thus, nesting deformation caused by overlarge hardness difference of the pushing rod 4 and the plugging agent in the process of pushing and tamping the plugging agent is avoided.

In this embodiment, the conveying rod 1 has an inner cavity for accommodating the balloon catheter, the push rod 4, the plugging agent section 5 and the anti-failure section 6, the push rod 4 is arranged in the conveying rod 1 in a penetrating manner and sleeved outside the catheter 2, the plugging agent section 5 and the anti-failure section 6 are arranged in the conveying rod 1 and sleeved outside the catheter 2, the plugging agent section 5 and the anti-failure section 6 are of tubular structures, the cross section of the plugging agent section 5 is annular, and the cross section of the anti-failure section 6 is annular. In other embodiments, the push rod 4 may be provided in other shapes in the gap between the delivery rod 1 and the catheter 2, as long as the function for pushing and tamping the plugging agent is achieved; the blocking agent section 5 and the failure prevention section 6 may be provided in other shapes located in the gap between the conveying rod 1 and the catheter 2 as long as the blocking function of the puncture hole and the blocking agent failure prevention function, such as two or more circular arc pieces, can be achieved.

Specifically, the anti-failure section 6 and the plugging agent section 5 are both sleeved outside the catheter 2, the cross section of the anti-failure section is annular or arc-shaped, and the inner diameter and the outer diameter of the anti-failure section 6 are respectively equal to those of the plugging agent section 5. The inner diameter and the outer diameter of the plugging agent section 5 and the inner diameter of the anti-failure section 6 are kept equal, so that the end face of the plugging agent section 5 and the end face of the anti-failure section 6 are completely attached, and when acting force is received, the end face of the plugging agent section 5 is completely stressed and all parts are uniformly stressed.

In this embodiment, the dimensions of the blocking agent section 5 and the failure prevention section 6 are selected to be different inside and outside diameter dimensions when applied to different wounds, the inside diameter dimension ranges from 0.6mm to 1.2mm, and the outside diameter dimension ranges from 1.5 mm to 2.5mm. The inner diameter and the outer diameter of the plugging agent section 5 and the failure prevention section 6 are in a proper range, and when the pressure is acted in the range, the deformation caused by the overlarge pressure is avoided.

The total length of the plugging agent section 5 and the anti-failure section 6 ranges from 15mm to 20mm, wherein the length of the anti-failure section 6 accounts for 10% -30%, and the length of the plugging agent section 5 accounts for 70% -90%. So make prevent that the section of becoming invalid is in suitable scope, avoid preventing that the section of becoming invalid is too short to lead to not playing the effect of preventing becoming invalid to prevent that the section overlength of becoming invalid leads to the shutoff agent section not enough to influence the shutoff effect to the puncture. Specifically, for example, the total length of the plugging agent section 5 and the fail-safe section 6 may be set to 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, and the length ratio of the fail-safe section 6 may be set to 10%, 12%, 14%, 16%, 19%, 21%, 24%, 26%, 29%, 30%.

Specifically, in one embodiment, the length of the plugging agent segment 5 is 13mm, the inner diameter is 0.70mm, the outer diameter is 1.50mm, the length of the failure prevention segment 6 is 3mm, the inner diameter is 0.70mm, and the outer diameter is 1.50mm; in another embodiment, the length of the plugging agent section 5 is 13mm, the inner diameter is 0.7mm, the outer diameter is 1.8mm, the length of the failure prevention section 6 is 3mm, the inner diameter is 0.7mm, and the outer diameter is 1.8mm; in another embodiment, the length of the plugging agent segment 5 is 13mm; the inner diameter is 0.8mm, the outer diameter is 2.10mm, the length of the failure prevention section 6 is 3mm, the inner diameter is 0.8mm, and the outer diameter is 2.10mm; in another embodiment, the length of the plugging agent segment 5 is 13mm; the inner diameter is 0.8mm, the outer diameter is 2.43mm, the length of the failure prevention section 6 is 3mm, the inner diameter is 0.8mm, and the outer diameter is 2.43mm.

In this embodiment, specifically, a section of failure prevention section 6 non-fixedly connected with the plugging agent section 5 is disposed on one side, close to the push rod 4, of the plugging agent section 5, the failure prevention section 6 is located between the plugging agent section 5 and the push rod 4 in the axial direction of the conveying rod 1, the end faces, connected with the plugging agent section 5, of the failure prevention section 6 are non-adhesive, flat, parallel and mutually abutted, the end faces are perpendicular to the central axis of the device, the failure prevention section 6 and the plugging agent section 5 are of tubular structures, the cross sections of the failure prevention section 6 and the plugging agent section 5 are annular, have the same inner diameter and outer diameter, and are made of the same materials, the material hardness of the failure prevention section 6 is equal to that of the plugging agent section 5, and biomedical materials which can be absorbed by human bodies are adopted.

The failure prevention section 6 has two possible situations in the using process of the equipment, and the two situations can realize the prevention of the arrangement failure of the plugging agent section 5, thereby improving the success rate of the application of the equipment. In the first case, when the balloon 3 is retracted and withdrawn, if clamping problem occurs, the anti-failure section 6 is carried out by clamping when the equipment is withdrawn, the plugging agent section 5 is separated from the anti-failure section 6, and the plugging agent section 5 still remains on the affected part to exert the plugging and hemostasis effects; in the second case, when the balloon 3 is retracted and withdrawn, if no clamping problem occurs, the plugging agent section 5 and the failure prevention section 6 both remain on the affected part to exert the plugging and hemostasis effects after the device is withdrawn. In both cases, the plugging agent section 5 can be left in the human body and absorbed in the human body, so that the device can cope with different conditions of puncture positions of different patients, the fault tolerance is improved, and the success rate of appliance application is ensured.

For the failure prevention section 6, the same biomedical material as the plugging agent section 5 may be used, or a biomedical material different from the plugging agent section 5 may be used.

In this embodiment, the blocking agent section 5 and the failure prevention section 6 are both prepared by freeze drying a cross-linked polymer, and are formed into porous materials, which have the characteristics of absorbing blood expansion, softness and smooth surface. Specifically, monomers respectively containing ester groups and amine groups are used for crosslinking reaction, freeze-drying is carried out to obtain freeze-dried hydrogel, and then further treatment is carried out to obtain the plugging agent section 5 and the failure prevention section 6. The monomer may be polyethylene glycol and its derivatives, and/or chitosan and its derivatives.

Polyethylene glycol and derivatives thereof, which may include polyethylene glycol derivatives having at least two end groups and at least one end group capable of crosslinking, or polyethylene glycol first functional groups may chemically react in situ with second functional groups to form covalent bonds, thereby forming gels capable of crosslinking.

In some embodiments, the first functional group or the second functional group can include a strong electrophile. For example, the first and second functional groups may be one or more of an epoxide, a succinimide, an N-hydroxysuccinimide, an acrylate, a methacrylate, a maleimide, and an N-hydroxysulfosuccinimide.

Alternatively, in some embodiments, the first functional group and/or the second functional group may be an amine group, a thiol group, a carboxyl group, and/or a hydroxyl group.

In other embodiments, the failure prevention section 6 may also be made of a different biomedical material than the blocking agent section 5, such as sodium hyaluronate, sodium alginate, collagen, and mixtures thereof.

Embodiment two:

The present embodiment provides an apparatus for sealing a puncture hole, which is different from the first embodiment in that the failure prevention section 6 employs a biomedical material that is not absorbable by a human body, and has the following technical features.

The difference from the first embodiment is that the failure prevention section 6 is made of biomedical materials which are not absorbable by human body, such as medical rubber, medical silica gel, etc. During use of the device, the fail-safe section 6 is carried out by the device when a clamping problem occurs and remains in the body when no clamping problem occurs.

Specifically, in this embodiment, for the failure prevention section 6, a pipe having the same inner diameter and outer diameter as the plugging agent section 5 may be used, the outer surface of the end face of the pipe is polished to be smooth, the end face in contact with the plugging agent section 5 is kept flat, non-adhesive, parallel to each other, and perpendicular to the central axis of the conveying rod 1, and is non-fixedly connected with the plugging agent section 5. The material of the anti-failure section 6 is different from that of the plugging agent section 5, the hardness of the anti-failure section 6 is larger than or equal to that of the plugging agent section 5 and smaller than or equal to that of the push rod 4, and the hardness difference between the anti-failure section 6 and the plugging agent section 5 is in the range of 0-20 degrees. When the balloon 3 is retracted and withdrawn, there may be two possible situations:

Firstly, when the sacculus 3 is retracted and withdrawn, if clamping problems occur, the failure prevention section 6 can be clamped and taken out when the equipment is withdrawn, the plugging agent section 5 can be separated from the failure prevention section 6, and the plugging agent section is left at an affected part to exert plugging and hemostasis effects;

Second, when the balloon 3 is retracted and withdrawn, if no clamping problem occurs, the device withdraws the plugging agent section 5 and the failure prevention section 6 to remain on the affected part, and the plugging agent section 5 remains on the affected part to exert the plugging and hemostasis effects.

The two conditions do not influence the absorption of the plugging agent section 5 in the human body and the successful arrangement in the human body, so that the device can cope with different conditions of puncture positions of different patients, the fault tolerance is improved, and the success rate of appliance application is ensured.

Embodiment III:

The present embodiment provides an apparatus for sealing a puncture hole, having the following technical features.

The difference from the first embodiment is that the fail-safe section is arranged to be carried out by the device upon or after the balloon 3 has been withdrawn.

In this embodiment, the anti-failure section 6 is fixedly connected to the device, such as to the distal end of the push rod 4, or by providing a connecting wire, and withdrawing the device while or after withdrawing the anti-failure section 6 from the human body.

Further, the anti-failure section 6 is made of a material which has certain strength and is not easy to crack, and can be stably taken out by an instrument. Upon withdrawal of the device, the failure prevention section 6 separates from the blocking agent and withdraws with the device.

Embodiment four:

The difference from the first embodiment is that the failure prevention section 6 is not deformed in the axial direction of the device under the extrusion when the balloon 3 is withdrawn, so that the failure prevention section 6 is not clamped into a gap between the push rod and the catheter during the withdrawal of the balloon 3, thereby ensuring that the plugging agent section is left in the body during the withdrawal of the device, and realizing the successful arrangement of the plugging agent. After the device is withdrawn, both the sealant segment 5 and the failure prevention segment 6 remain in the human body, or the failure prevention segment 6 is withdrawn after the balloon 3 is withdrawn, or the failure prevention segment 6 is withdrawn after the device is withdrawn.

For this embodiment, the fail-safe section 6 and the sealant section 5 are not fixedly connected. Thus, the anti-failure section can be selected to be left in the body or withdrawn according to actual requirements.

In this embodiment, the failure prevention section 6 left in the human body is made of an implantable biomedical material such as a polymer material or the like. The hardness of the material is the same as that of the plugging agent section 5, or the material is more than or equal to that of the plugging agent section 5 and less than or equal to that of the push rod 4, and the hardness difference between the failure prevention section 6 and the plugging agent section 5 is between 0 and 20 degrees.

Fifth embodiment:

the present embodiment provides an apparatus for sealing a puncture hole having the following technical features in addition to the technical scheme including the above embodiment.

The difference from the fourth embodiment is that the failure prevention section 6 is not deformed in the axial direction of the device under the pressing force when the balloon 3 is withdrawn, the plugging agent section 5 and the failure prevention section 6 are fixedly connected, and the plugging agent section 5 and the failure prevention section 6 remain in the human body after the balloon 3 and the device are withdrawn. Therefore, the stress is more uniform when the fixed connection between the failure prevention section 6 and the plugging agent section 5 is extruded, and the failure prevention section 6 and the plugging agent section 5 are not easy to deform to form clamping.

Example six:

the present embodiment provides an apparatus for sealing a puncture hole, which is different from the first embodiment in that the end face of the plugging agent section 5 facing the failure prevention section 6 and the end face of the failure prevention section 6 facing the plugging agent section 5 are non-adhesive, the contact surface between the plugging agent section 5 and the failure prevention section 6 is non-adhesive when in contact, and the deformation of the failure prevention section 6 in the axial direction of the apparatus does not occur when the balloon is compressed when it is withdrawn. So that the successful arrangement of the plugging agent can be ensured in double, and the success rate of the equipment is further improved.

Embodiment seven:

This embodiment provides a specific arrangement of the blocking agent segment 5, and as shown in fig. 6, an additional preparation segment 501 is further provided on the blocking agent segment 5, where the additional preparation segment 501 is a preparation with at least one special effect of adhering to blood vessels, promoting coagulation, locally relieving pain, promoting tissue repair growth, and reducing inflammation.

Specifically, the additional formulation section 501 is disposed at the distal end of the plugging agent section 5. The plugging agent section 5 may be configured to form a head end at the distal end of the plugging agent section 5 by using a mixture of non-crosslinked polymer precursors, or may be formed with additional formulation by adding additional formulation in the distal portion of the plugging agent section 5.

Further, the plugging agent section 5 can form a head end at the distal end of the plugging agent section 5 by using a mixture of non-crosslinked polymer precursors, so that in-situ crosslinking reaction can occur when the plugging agent section contacts with blood in a human body, and the plugging agent section is adhered to the surface of a blood vessel, thereby enhancing the plugging hemostatic effect; the distal end with additional formulation, including but not limited to chitosan, clotting factors, etc., may also be formed by adding additional formulation to the distal portion of the occluding agent segment 5, which may promote accelerated clotting of blood near the wound, reduce bleeding, and enhance hemostatic effects in humans. The distal additional formulation may be analgesic, including but not limited to lidocaine, tetracaine, etc., released at the wound site to provide a local analgesic effect.

In other embodiments, the additional formulation section 501 may be disposed proximal to the plugging agent section 5 or at any one or all of the sections, the plugging agent section 5 may be attached to the plugging agent section 5 by using a mixture of non-crosslinked polymer precursors, or additional formulation may be added to the plugging agent section 5 by requiring some or all of the addition of additional formulation.

Example eight:

the present embodiment provides an apparatus for sealing a puncture hole, and provides a specific embodiment in which the failure prevention section 6 is made of a biomedical material absorbable by a human body, having the following technical features.

The material of the anti-failure section 6 adopts biomedical materials which can be absorbed by human bodies, so that the anti-failure section 6 can enhance the plugging and hemostasis effects when left in the human bodies, and the anti-failure section 6 can prevent the arrangement failure of the plugging agent section 5 when taken out of the human bodies.

The biomedical material comprises a high molecular polymer or biological tissue, the high molecular polymer comprises but is not limited to: polyethylene glycol polymer and its derivatives, polyglycolic acid, polylactic acid, polyvinyl alcohol, polyglycolic acid-polylactic acid copolymer, polylactide copolymer, chitosan, collagen, cellulose, sodium alginate, sodium hyaluronate, gelatin, etc.; biological materials include, but are not limited to: animal cells, tissues or other extracts.

Depending on the embodiment, polyethylene glycol, chitosan, collagen, cellulose, sodium alginate, etc. can all be of different types.

For example, polyethylene glycol can be a modified derivative, non-limiting examples of polyethylene glycol derivatives that can be used include, but are not limited to, branched polyethylene glycol derivatives, hetero-functional polyethylene glycol derivatives, linear mono-functional polyethylene glycol derivatives, and even combinations thereof. Non-limiting examples of branched polyethylene glycol derivatives include, but are not limited to, Y-PEG NHS esters, Y-PEG maleimides, Y-PEG acetaldehyde, Y-PEG propionaldehyde. Non-limiting examples of hetero-functional polyethylene glycol derivatives include, but are not limited to, hydroxy PEG carboxyl groups, hydroxy PEG amines, HCl salts, amine PEG carboxyl groups, HCl salts, acrylate PEG NHS esters, maleimide PEG amines, TFA salts, maleimide PEG NHS esters, 4-arm PEG succinimidyl succinate pentaerythritol, 4-arm PEG carboxymethyl-hydroxybutyrate-N-hydroxysuccinimidyl esters, 4-arm PEG succinimidyl glutarate, 4-arm PEG amines, 8-arm PEG amine salts. Non-limiting examples of linear monofunctional polyethylene glycol derivatives include, but are not limited to, methoxy PEG succinimidyl carboxymethyl ester, methoxy PEG maleimide, methoxy PEG vinyl sulfone, methoxy PEG mercapto, methoxy PEG propionaldehyde, methoxy PEG amine, HCl salts. The molecular weight of the polyethylene glycol derivative may be between about 2500-50000 Da.

For example, the chitosan can be free chitosan, chlorinated chitosan, chitosan glutamate, chitosan acetate, chitosan dicarboxylate, chitosan adipate, chitosan succinate, or chitosan fumarate, and even combinations thereof. Chitosan can be at least partially deacetylated, which can range between 50% and 99%.

For example, the collagen may be type I, type II, type III, type V, and type XI, and combinations thereof.

For example, the cellulose may be methylcellulose, carboxymethylcellulose, ethylcellulose, hydroxyethylcellulose, cyanoethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, cellulose nitrate, cellulose acetate butyrate and cellulose xanthate, and even combinations thereof. The molecular weight of the cellulose may be between 500 and 20000 Da.

For example, sodium alginate can be a derivative thereof, and may be acetylated sodium alginate, phosphorylated sodium alginate, sulfated sodium alginate, oxidized sodium alginate.

Working principle: as shown in fig. 7, when the blood return hole 101 of the delivery rod 1 reaches the blood 93 by passing the head of the apparatus, that is, the portion of the area a in fig. 1, through the puncture hole and the blood vessel wall 92 in the human tissue 91 into the blood 93, the blood flows from the blood return hole 101 into the cavity 401 behind the push rod 4, the cavity 401 communicates with the portion of the apparatus located outside the human tissue 91, and it is observed that the blood outflow instruction has reached the blood 93; at this time, physiological saline or other filler is filled into the balloon 3 through the catheter 2, and the balloon 3 is inflated; at this time, the device is pulled outwards, so that the bulged saccule 3 is propped against the vascular wall 92, the positioning of the vascular wall 92 is completed, and the plugging agent section 5 can be released at the tail end of the puncture hole; at this time, after the positioning is completed, the filling material in the balloon 3 is discharged through the catheter 2, so that the balloon 3 is contracted, the balloon 3 is extracted, and the plugging agent section 5 is left in the puncture hole, in the prior art, the plugging agent section 5 is easily clamped in the push rod 4 and is carried out together, so that the end of the plugging agent section 5 is provided with an anti-failure section 6 with a non-adhesive end face, and the anti-failure section 6 can be clamped by the push rod 4 and carried out or left in the puncture hole when the anti-failure section 6 is in non-fixed connection with the plugging agent section 5; the anti-failure section 6 can also be made of a material which is extruded and does not deform upwards along the axial direction of the device when the balloon 3 is withdrawn, and the anti-failure section 6 does not deform and is not clamped in the push rod 4 when the balloon 3 is withdrawn; both the two modes can avoid the failure of the plugging agent arrangement caused by the plugging agent section 5 being clamped and carried out by the equipment; as shown in fig. 8, a schematic view of the expansion of the plugging agent in the puncture after releasing the plugging agent segment 5 and the failure prevention segment 6 is shown.

To sum up, this a device for sealing puncture hole, through set up the section of preventing becoming invalid between shutoff agent section and push rod, the section of preventing becoming invalid can prevent that shutoff agent section from being held to the push rod when the sacculus withdraws to avoided the shutoff agent section to bring out when the device withdraws from and lead to the shutoff agent to arrange the inefficacy.

This a device for sealing puncture hole sets up through the one end that is close to push rod 4 at blocking agent section 5 and prevents inefficacy section 6 with blocking agent section 5 non-fixed connection, does not have the adhesion property when blocking agent section 5 and the terminal surface contact of preventing inefficacy section 6, thereby prevent inefficacy section 6 and blocking agent section 5 do not form fixed connection and make prevent inefficacy section 6 whether by push rod 4 gap centre gripping can not influence blocking agent section 5, guaranteed blocking agent section 5 can not be taken out by the device and lead to arranging the inefficacy.

This a device for sealing puncture hole sets up through the one end that is close to push rod 4 at shutoff agent section 5 and prevents inefficacy section 6, prevents inefficacy section 6 through adopting and receives the extrusion when sacculus 3 withdraws and take place along the material of equipment axial deformation, when equipment release shutoff agent section 5 and prevent inefficacy section 6 get into the human body, prevents inefficacy section 6 can not by extrusion deformation to prevent inefficacy section 6 can not be carried out in the push rod 4 by the centre gripping because of sacculus 3 withdraws, realize successful shutoff agent's arrangement.

It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions, combinations and alterations may be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims

1. An apparatus for sealing a puncture, comprising:

A conveying rod (1) for penetrating into the puncture hole;

The balloon catheter comprises a catheter (2) and a balloon (3) communicated with the catheter (2), wherein the catheter (2) is arranged in the conveying rod (1) in a penetrating mode and is used for enabling the balloon (3) to bulge or shrink, the balloon (3) is arranged at the far end of the catheter (2) and is at least partially positioned at the outer side of the end part of the conveying rod (1), and the balloon (3) is used for positioning a vascular wall (92) when the balloon bulges;

A push rod (4) arranged in a gap between the conveying rod (1) and the guide pipe (2);

A plugging agent section (5) located inside the delivery rod (1) at one end close to the balloon (3), the plugging agent section (5) being located in the gap between the catheter (2) and the delivery rod (1);

The anti-failure section (6) is arranged in a gap between the conveying rod (1) and the catheter (2), is positioned between the plugging agent section (5) and the push rod (4) in the axial direction of the conveying rod (1), and the anti-failure section (6) is used for preventing the plugging agent section (5) from being taken out when the device is withdrawn.

2. An apparatus for sealing a puncture according to claim 1, characterized in that the plugging agent section (5) is not fixedly connected to the fail-safe section (6), that the end face of the plugging agent section (5) facing the fail-safe section (6) is non-adhesive with the end face of the fail-safe section (6) facing the plugging agent section (5), that the contact surface between the plugging agent section (5) and the fail-safe section (6) is non-adhesive upon contact;

And/or the failure prevention section (6) is not deformed along the axial direction of the device under extrusion.

3. An apparatus for sealing a puncture according to claim 2, characterized in that the end face of the plugging agent section (5) facing the fail-safe section (6) is leveled with the end face of the fail-safe section (6) facing the plugging agent section (5), and the end face of the plugging agent section (5) facing the fail-safe section (6) is leveled with the end face of the fail-safe section (6) facing the plugging agent section (5).

4. A device for sealing a puncture according to claim 3, characterized in that the end face of the plugging agent section (5) facing the failure prevention section (6) and the end face of the failure prevention section (6) facing the plugging agent section (5) are both perpendicular to the central axis of the conveying rod (1).

5. An apparatus for sealing a puncture according to claim 4, characterized in that the fail-safe section (6) is arranged at an end of the plugging agent section (5) close to the push rod (4), the end face of the plugging agent section (5) facing the fail-safe section (6) and the end face of the fail-safe section (6) facing the plugging agent section (5) being in abutment with each other; the material hardness of the anti-failure section (6) is the same as that of the plugging agent section (5), or the material hardness of the anti-failure section (6) is greater than that of the plugging agent section (5) and less than that of the push rod (4).

6. An apparatus for sealing a puncture according to claim 2, characterized in that the failure prevention section (6) and the plugging agent section (5) are both sleeved outside the catheter (2), the cross section is annular or arc-shaped, and the inner diameter and the outer diameter of the failure prevention section (6) and the inner diameter and the outer diameter of the plugging agent section (5) are respectively kept equal.

7. An apparatus for sealing a puncture according to claim 6, characterized in that the inner diameter of the plugging agent section (5) and the fail-safe section (6) is in the size range of 0.6-1.2mm, and the outer diameter of the plugging agent section (5) and the fail-safe section (6) is in the size range of 1.5-2.5mm.

8. An apparatus for sealing a puncture according to claim 7, characterized in that the total axial length of the plugging agent section (5) and the fail-safe section (6) is in the range of 15-20mm and the axial length of the fail-safe section is in the range of 10% -30%.

9. The device for sealing a puncture according to claim 2, characterized in that the material of the fail-safe section (6) is a biomedical material absorbable by the human body, the biomedical material in the fail-safe section (6) comprising a high molecular polymer comprising at least one or a combination of polyethylene glycol polymer and its derivatives, polyglycolic acid, polylactic acid, polyvinyl alcohol, polyglycolic acid-polylactic acid copolymer, polylactide copolymer, chitosan, collagen, cellulose, sodium alginate, sodium hyaluronate and gelatin, or a biomaterial comprising at least one or a combination of animal cells, tissues and other extracts;

Or the material of the failure prevention section (6) adopts biomedical materials which cannot be absorbed by human bodies.

10. An apparatus for sealing a puncture according to claim 2, characterized in that the plugging agent section (5) is further provided with an additional preparation section (501), which additional preparation section (501) is a preparation having at least one special effect of adhering to blood vessels, promoting blood clotting, local pain relieving, promoting tissue repair growth and reducing inflammation.